UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT
OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
August 8, 2013
NOVO
NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F [X]
|
Form 40-F [ ]
|
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ]
|
No [X]
|
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_____________________
Financial report for the period 1 January 2013 to 30 June 2013
8 August 2013
Novo
Nordisk increased operating profit by 15% in the first six months of 2013
Sales growth
of 11% driven by Victoza®, NovoRapid® and Levemir®
Sales increased by 14% in local currencies and by 11% in Danish kroner to DKK 41.4 billion. | |
| Sales of modern insulins increased by 15% (13% in Danish kroner). |
| Sales of Victoza® increased by 32% (30% in Danish kroner). |
| Sales in North America increased by 23% (21% in Danish kroner). |
| Sales in International Operations increased by 17% (12% in Danish kroner). |
Gross margin improved by 0.9 percentage points in Danish kroner to 82.6%, reflecting a favourable price and product mix development.
Operating profit increased by 19% in local currencies and by 15% in Danish kroner to DKK 16.1 billion.
Net profit increased by 27% to DKK 12.7 billion. Diluted earnings per share increased by 30% to DKK 23.43.
The launch of Tresiba® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action continues. Tresiba® has now also been commercially launched in Mexico and Switzerland. In the US, Novo Nordisk has received feedback from FDA on the clinical trial protocol for the cardiovascular outcomes trial for Tresiba® confirming the previously announced expectations to trial design.
Novo Nordisk has now successfully completed the SCALE phase 3a clinical programme investigating the efficacy and safety of liraglutide 3 mg for the treatment of obesity. Novo Nordisk expects to file liraglutide 3 mg for regulatory review in the US and EU around the turn of the year.
For 2013, expectations to operating performance have been raised. Sales growth measured in local currencies is now expected to be 11-13%, whereas operating profit growth measured in local currencies is now expected to be 12-15%.
Lars Rebien Sørensen, president and CEO: We are pleased with the strong results in the first six months of 2013. Our portfolio of modern insulins and Victoza® are driving solid sales growth. Based on the feedback from FDA in the US regarding the design of the cardiovascular outcomes trial for Tresiba®, we now expect to start the trial before the end of the year.
Novo Nordisk A/S Investor Relations |
Novo
Allé
2880
Bagsværd
Denmark |
Telephone:
+45
4444 8888
www.novonordisk.com |
CVR
No:
24
25 67 90
|
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
2 of 30
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ABOUT NOVO NORDISK
Novo
Nordisk is a global healthcare company with 90 years of innovation and leadership
in diabetes care. The company also has leading positions within haemophilia
care, growth hormone therapy and hormone replacement therapy. Headquartered
in Denmark, Novo Nordisk employs approximately 36,000 employees in 75 countries,
and markets its products in more than 180 countries. Novo Nordisks B shares
are listed on NASDAQ OMX Copenhagen (Novo-B) and its ADRs are listed on the
New York Stock Exchange (NVO).
CONFERENCE
CALL DETAILS
On 8 August 2013 at 13.00 CEST, corresponding to 7.00 am EDT, a conference call
will be held. Investors will be able to listen in via a link on novonordisk.com,
which can be found under Investors Download centre. Presentation
material for the conference call will be available approximately one hour before
on the same page.
WEB CAST DETAILS
On 9 August 2013
at 12.30 CEST, corresponding to 6.30 am EDT, management will give a presentation
to institutional investors and sell side-analysts in London. A webcast of the
presentation can be followed via a link on novonordisk.com,
which can be found under Investors Download centre. Presentation
material for the conference call will be made available on the same page.
FINANCIAL CALENDAR | |
24 September 2013 | Novo Nordisk's investor and analyst event at EASD |
31 October 2013 | Financial statement for the first nine months of 2013 |
3 December 2013 | Capital Markets Day |
30 January 2014 | Financial statement for 2013 |
CONTACTS FOR FURTHER INFORMATION | ||
Media: | ||
Mike Rulis | +45 4442 3573 | mike@novonordisk.com |
Ken Inchausti (US) | +1 609 514 8316 | kiau@novonordisk.com |
Investors: | ||
Kasper Roseeuw Poulsen | +45 4442 4303 | krop@novonordisk.com |
Frank Daniel Mersebach | +45 4442 0604 | fdni@novonordisk.com |
Lars Borup Jacobsen | +45 3075 3479 | lbpj@novonordisk.com |
Daniel Bohsen | + 45 3079 6376 | dabo@novonordisk.com |
Jannick Lindegaard (US) | +1 609 786 4575 | jlis@novonordisk.com |
Further information about Novo Nordisk is available on the companys website novonordisk.com.
Company announcement No 54 / 2013
Financial report for the period 1 January 2013 to 30 June 2013 |
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Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Legal
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Financial
information |
Company
announcement No 54 / 2013
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Financial report for the period 1 January 2013 to 30 June 2013 |
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CONSOLIDATED
FINANCIAL STATEMENT FOR THE FIRST SIX MONTHS OF 2013
These unaudited
consolidated financial statements for the first six months of 2013 have been
prepared in accordance with IAS 34 Interim Financial Reporting and
on the basis of the same accounting policies as were applied in the Annual
Report 2012 of Novo Nordisk. Furthermore, the financial report including
the consolidated financial statements for the first six months of 2013 and Managements
review have been prepared in accordance with additional Danish disclosure requirements
for interim reports of listed companies. Novo Nordisk has adopted all new, amended
or revised accounting standards and interpretations (IFRSs) as published
by the IASB, and also those that are endorsed by the EU effective for the accounting
period beginning on 1 January 2013. These IFRSs have not had a significant impact
on the consolidated financial statements for the first six months of 2013.
Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees.
|
|
|
|
|
|
|
PROFIT AND LOSS |
H1
2013
|
H1
2012
|
%
change
H1
2012
to
H1 2013
|
|||
DKK million | ||||||
|
|
|
|
|
|
|
Sales |
41,363
|
37,219
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11%
|
|||
|
|
|
|
|
|
|
Gross profit |
34,148
|
30,392
|
12%
|
|||
Gross margin |
82.6%
|
81.7%
|
||||
Sales and distribution costs |
11,364
|
10,053
|
13%
|
|||
Percent of sales |
27.5%
|
27.0%
|
||||
Research and development costs |
5,372
|
5,070
|
6%
|
|||
Percent of sales |
13.0%
|
13.6%
|
||||
Administrative costs |
1,616
|
1,555
|
4%
|
|||
Percent of sales |
3.9%
|
4.2%
|
||||
Licence income and other operating income |
351
|
324
|
8%
|
|||
|
|
|
|
|
|
|
Operating profit |
16,147
|
14,038
|
15%
|
|||
Operating margin |
39.0%
|
37.7%
|
||||
Net financials |
303
|
(1,038)
|
(129%)
|
|||
|
|
|
|
|
|
|
Profit before income taxes |
16,450
|
13,000
|
27%
|
|||
|
|
|
|
|
|
|
Net profit |
12,716
|
10,010
|
27%
|
|||
Net profit margin |
30.7%
|
26.9%
|
||||
|
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|
|
|
|
|
OTHER KEY NUMBERS | ||||||
|
|
|
|
|
|
|
Depreciation, amortisation and impairment losses |
1,367
|
1,294
|
6%
|
|||
Capital expenditure |
1,560
|
1,371
|
14%
|
|||
Net cash generated from operating activities |
14,353
|
12,738
|
13%
|
|||
Free cash flow |
12,601
|
11,311
|
11%
|
|||
Total assets |
64,289
|
60,978
|
5%
|
|||
Equity |
35,357
|
31,334
|
13%
|
|||
Equity ratio |
55.0%
|
51.4%
|
||||
Average number of diluted shares outstanding (million) |
542.6
|
556.4
|
(2%)
|
|||
Diluted earnings per share / ADR (in DKK) |
23.43
|
17.99
|
30%
|
|||
Full-time equivalent employees end of period |
35,869
|
32,819
|
9%
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|||
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Financial
performance |
Outlook
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R&D
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Sustainability
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Equity
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Legal
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Financial
information |
Company
announcement No 54 / 2013
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Financial report for the period 1 January 2013 to 30 June 2013 |
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SALES
DEVELOPMENT
Sales increased
by 14% measured in local currencies and by 11% in Danish kroner. North America
was the main contributor with 70% share of growth measured in local currencies,
followed by International Operations and Region China contributing 18% and 9%
respectively. Sales growth was realised within both diabetes care and biopharmaceuticals,
with the majority of growth originating from the modern insulins and Victoza®.
Sales growth has been positively impacted by approximately 2 percentage points
due to a number of non-recurring events including adjustments in the provisions
for rebates in North America as well as the timing of tenders and shipments
and extraordinary sales in International Operations.
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Sales
H1 2013 DKK million |
Growth
as reported |
Growth
in local currencies |
Share
of
growth in local currencies |
|||||
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|
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|
|
|
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|
|
The diabetes care segment | ||||||||
- NovoRapid ® |
8,300
|
13%
|
15%
|
22%
|
||||
- NovoMix ® |
4,884
|
9%
|
12%
|
10%
|
||||
- Levemir ® |
5,433
|
17%
|
19%
|
18%
|
||||
Modern insulins |
18,617
|
13%
|
15%
|
50%
|
||||
Human insulins |
5,603
|
2%
|
4%
|
4%
|
||||
Victoza® |
5,555
|
30%
|
32%
|
27%
|
||||
Protein-related products |
1,249
|
0%
|
4%
|
1%
|
||||
Oral antidiabetic products (OAD) |
1,375
|
0%
|
2%
|
0%
|
||||
Diabetes care total |
32,399
|
12%
|
14%
|
82%
|
||||
|
|
|
|
|
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|
|
|
The biopharmaceuticals segment | ||||||||
NovoSeven® |
4,569
|
5%
|
7%
|
6%
|
||||
Norditropin® |
3,016
|
8%
|
14%
|
8%
|
||||
Other biopharmaceuticals |
1,379
|
15%
|
18%
|
4%
|
||||
Biopharmaceuticals total |
8,964
|
7%
|
11%
|
18%
|
||||
|
|
|
|
|
|
|
|
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Total sales |
41,363
|
11%
|
14%
|
100%
|
||||
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Please refer to appendix 6 for further details on sales in the first six months of 2013.
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from May 2013 and May 2012 provided by the independent data provider IMS Health.
DIABETES
CARE SALES DEVELOPMENT
Sales
of diabetes care products increased by 14% measured in local currencies and
by 12% in Danish kroner to DKK 32,399 million. Novo Nordisk is the world leader
in diabetes care and now holds a global value market share of 27% compared to
25% at the same time the year before.
Financial
performance |
Outlook
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R&D
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Sustainability
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Legal
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Financial
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Company
announcement No 54 / 2013
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Financial report for the period 1 January 2013 to 30 June 2013 |
Page
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Insulins and
protein-related products
Sales
of modern insulins, human insulins and protein-related products increased by
12% in local currencies and by 10% in Danish kroner to DKK 25,469 million. Measured
in local currencies, sales growth was driven by North America, International
Operations and Region China. Novo Nordisk is the global leader with 49% of the
total insulin market and 46% of the market for modern insulin and new-generation
insulin, both measured in volume.
The launch of Tresiba® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action, continues. Tresiba® has now, in addition to the UK, Denmark and Japan, also been commercially launched in Mexico and Switzerland. Launch activities are progressing as planned and feedback from patients and prescribers is encouraging.
Sales of modern insulins increased by 15% in local currencies and by 13% in Danish kroner to DKK 18,617 million. North America accounted for two thirds of the growth, followed by International Operations and Region China. Sales of modern insulins now constitute 77% of Novo Nordisks sales of insulin.
|
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|
|||||
INSULIN
MARKET SHARES (volume, MAT) |
Novo
Nordisks share of total insulin market |
Novo
Nordisks share of the modern insulin and new-generation insulin market |
||||||
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|
|
|
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|||
May
|
May
|
May
|
May
|
|||||
2013
|
2012
|
2013
|
2012
|
|||||
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Global |
49%
|
50%
|
46%
|
46%
|
||||
USA |
41%
|
41%
|
39%
|
37%
|
||||
Europe |
50%
|
51%
|
49%
|
50%
|
||||
International Operations* |
56%
|
58%
|
54%
|
55%
|
||||
China** |
60%
|
62%
|
64%
|
66%
|
||||
Japan |
53%
|
57%
|
49%
|
52%
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||||
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|
Source: IMS, May 2013 data. *: Data for 12 selected markets representing approximately 60% of Novo Nordisks diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
North America
Sales of insulins
and protein-related products in North America increased by 22% in local currencies
and by 20% in Danish kroner. Sales growth reflects a continued positive contribution
from pricing in the US, solid market penetration of all three modern insulins,
NovoLog®, Levemir® and NovoLog®
Mix 70/30 as well as human insulin sales growth. In addition, US sales are positively
impacted by an adjustment in the provisions for rebates related to prior years.
53% of Novo Nordisks modern insulin volume in the US is used in the prefilled
device FlexPen®.
Europe
Sales of insulins
and protein-related products in Europe decreased by 1%, both in local currencies
and Danish kroner. The development reflects that the declining human insulin
sales are only partially offset by the continued progress for Levemir®
and NovoRapid® and a very modest impact from a lower than normal
volume growth, below 2%, as well
Financial
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Outlook
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Company
announcement No 54 / 2013
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Page
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as the implementation of pricing reforms in several European markets. The device penetration in Europe remains high with 96% of Novo Nordisks insulin volume being used in devices, primarily NovoPen® and FlexPen®.
International
Operations
Sales
of insulins and protein-related products in International Operations increased
by 17% in local currencies and by 12% in Danish kroner. The growth, which is
positively impacted by the timing in tenders and shipments in a number of countries,
is driven by all three modern insulins and a solid contribution from human insulins.
Currently, 59% of Novo Nordisks insulin volume in the major private markets
is used in devices.
Region China
Sales
of insulins and protein-related products in Region China increased by 16% in
local currencies and by 17% in Danish kroner. The sales growth was driven by
all three modern insulins, while sales of human insulins only grew modestly.
Currently, 97% of Novo Nordisks insulin volume in China is used in devices,
primarily the durable device NovoPen®.
Japan &
Korea
Sales of insulins and protein-related products in Japan & Korea decreased
by 6% in local currencies and by 21% measured in Danish kroner. The sales development
reflects the negative impact of a stagnant Japanese insulin volume market and
a challenging competitive environment. The device penetration in Japan remains
high with 98% of Novo Nordisks insulin volume being used in devices, primarily
FlexPen®.
Victoza®
(GLP-1 therapy for type 2 diabetes)
Victoza®
sales increased by 32% in local currencies and by 30% in Danish kroner to DKK
5,555 million, reflecting robust sales performance driven by North America,
Europe and International Operations. Victoza® holds the global
market share leadership in the GLP-1 segment with a 69% value market share compared
to 64% in 2012. The GLP-1 segments value share of the total diabetes care
market has increased to 6.6% compared to 5.2% in 2012.
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|||||
GLP-1 MARKET
SHARES (value, MAT) |
GLP-1
share of total diabetes care market |
Victoza®
share of GLP-1 market |
||||||
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|||
May
2013 |
May
2012 |
May
2013 |
May
2012 |
|||||
|
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Global |
6.6%
|
5.2%
|
69%
|
64%
|
||||
USA |
8.2%
|
6.4%
|
65%
|
58%
|
||||
Europe |
7.3%
|
5.8%
|
78%
|
73%
|
||||
International Operations* |
2.9%
|
2.5%
|
78%
|
79%
|
||||
China** |
0.6%
|
0.4%
|
66%
|
23%
|
||||
Japan |
2.2%
|
2.1%
|
75%
|
82%
|
||||
|
|
|
|
|
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|
Source: IMS, May 2013 data. *: Data for 12 selected markets representing approximately 60% of Novo Nordisks diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.
Financial
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Page
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North America
Sales
of Victoza® in North America increased by 35% in local currencies
and by 33% in Danish kroner. This reflects a continued expansion of the GLP-1
class, which represents 8.2% of the total US diabetes care market in value compared
to 6.4% in 2012. Despite the launch of a competing product in 2012, Victoza®
continues to drive the US GLP-1 market expansion and is the GLP-1 market leader,
now with a 65% value market share compared to 58% a year ago.
Europe
Sales
in Europe increased by 26% in local currencies and by 25% in Danish kroner.
Sales growth is primarily driven by France, the UK, Spain and Italy. In Europe,
the GLP-1 class share of the total diabetes care market in value has increased
to 7.3% compared to 5.8% in 2012. Victoza® is the GLP-1 market
leader with a value market share of 78%.
International
Operations
Sales
in International Operations increased by 51% in local currencies and by 44%
in Danish kroner. This reflects continued market penetration, primarily driven
by Brazil and a number of Middle Eastern countries. The GLP-1 class is expanding
in International Operations and represents 2.9% of the total diabetes care market
in value compared to 2.5% in 2012. Victoza® is the GLP-1 market
leader across International Operations with a value market share of 78%.
Region China
Sales
in Region China increased by 123% in local currencies and by 126% in Danish
kroner. The GLP-1 class in China is not reimbursed and relatively modest in
size. However, its share of the total diabetes care market in value has expanded
to 0.6% compared to 0.4% in 2012. Victoza® holds a GLP-1 value
market share of 66%.
Japan &
Korea
Sales
in Japan & Korea decreased by 6% in local currencies and by 22% in Danish
kroner. The GLP-1 class in Japan is only expanding modestly and now represents
2.2% of the total diabetes care market in value compared to 2.1% in 2012. Victoza®
remains the leader in the Japanese GLP-1 class with a value market share of
75%.
NovoNorm®/Prandin®/PrandiMet®
(oral antidiabetic products)
Sales
of oral antidiabetic products increased by 2% in local currencies and were unchanged
in Danish kroner at DKK 1,375 million. The sales development reflects a positive
impact from pricing in the US, largely offset by declining sales in Europe due
to generic competition in several markets.
BIOPHARMACEUTICALS
SALES DEVELOPMENT
Sales
of biopharmaceutical products increased by 11% measured in local currencies
and by 7% in Danish kroner to DKK 8,964 million. Sales growth was primarily
driven by North America and International Operations.
Financial
performance |
Outlook
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Company
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NovoSeven®
(bleeding disorders therapy)
Sales of NovoSeven®
increased by 7% in local currencies and by 5% in Danish kroner to DKK 4,569
million. The market for NovoSeven® remains volatile and sales
growth is primarily driven by North America and International Operations.
Norditropin®
(growth hormone therapy)
Sales
of Norditropin® increased by 14% in local currencies and by 8%
in Danish kroner to DKK 3,016 million. The sales growth is primarily driven
by North America and by International Operations. Novo Nordisk is the leading
company in the global growth hormone market with a 25% market share measured
by volume.
Other biopharmaceuticals
Sales
of other products within biopharmaceuticals, which predominantly consist of
hormone replacement therapy (HRT)-related products, increased by 18% in local
currencies and by 15% in Danish kroner to DKK 1,379 million. Sales growth is
driven by North America and reflects a positive impact of pricing and non-recurring
rebate adjustments.
DEVELOPMENT
IN COSTS AND OPERATING PROFIT
The cost
of goods sold grew 6% to DKK 7,215 million, resulting in a gross margin of 82.6%
compared to 81.7% in 2012. This development primarily reflects an underlying
improvement driven by favourable price development in North America and a positive
net impact from product mix due to increased sales of modern insulins and Victoza®.
The gross margin was negatively impacted from currencies by around 0.2 percentage
point primarily as a result of depreciation of the Japanese yen versus the Danish
krone compared to prevailing exchange rates in 2012.
Total non-production-related costs increased by 12% in local currencies and by 10% in Danish kroner to DKK 18,352 million.
Sales and distribution costs increased by 15% in local currencies and by 13% in Danish kroner to DKK 11,364 million. The growth in costs is driven by the expansion of the US sales force in the second half of 2012 and sales and marketing investments in China and selected countries in International Operations, costs related to the launch of Tresiba® in Europe and Japan as well as an impact on the growth percentage for costs from reversals of legal provisions in the first half of 2012.
Research and development costs increased by 7% in local currencies and by 6% in Danish kroner to DKK 5,372 million. The modest cost increase reflects timing of clinical trial activity and is primarily driven by development costs related to the completion of the phase 3a programme for liraglutide 3 mg in obesity and the ongoing phase 3a trial for the once-weekly GLP-1 analogue semaglutide. Within biopharmaceuticals, costs are primarily related to the continued progress of the portfolio of development projects within haemophilia and the phase 2 trial for anti-IL-20, a recombinant human monoclonal antibody, in rheumatoid arthritis.
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Company
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Page
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|
Administration costs increased by 6% in local currencies and by 4% in Danish kroner to DKK 1,616 million. The increase in costs is primarily driven by back-office infrastructure costs to support the expansion of the sales organisation in North America and International Operations as well as an impact from a cost refund in the first half of 2012 of a previously expensed fine related to an import licence for a major market in International Operations.
Licence income and other operating income constituted DKK 351 million compared to DKK 324 million in 2012.
Operating profit in local currencies increased by 19% and by 15% in Danish kroner to DKK 16,147 million.
NET
FINANCIALS
Net financials showed
a net income of DKK 303 million compared to a net expense of DKK 1,038 million
in 2012.
In line with Novo Nordisks treasury policy, the most significant foreign exchange risks for the group have been hedged, primarily through foreign exchange forward contracts. The foreign exchange result was an income of DKK 368 million compared to an expense of DKK 963 million in 2012. This development reflects gains on foreign exchange hedging involving especially the Japanese yen and the US dollar due to their depreciation versus the Danish krone compared to the prevailing exchange rates in 2012. This positive effect is partly offset by losses on commercial balances, primarily related to non-hedged currencies.
CAPITAL
EXPENDITURE AND FREE CASH FLOW
Net capital
expenditure for property, plant and equipment was DKK 1.6 billion compared to
DKK 1.4 billion in 2012. Net capital expenditure was primarily related to filling
capacity in Denmark and Russia, new offices in Denmark, new diabetes research
facilities in Denmark as well as device production facilities in the US and
Denmark.
Free cash flow was DKK 12.6 billion compared to DKK 11.3 billion in 2012. The increase of 11% compared to 2012 reflects the growth in net profit of 27% being partially countered by payment of rebate liabilities in the US.
KEY
DEVELOPMENTS IN THE SECOND QUARTER OF 2013
Please
refer to appendix 1 for an overview of the quarterly numbers in DKK and appendix
6 for details on sales in the second quarter of 2013.
Sales in the second quarter of 2013 increased by 13% in local currencies and by 10% in Danish kroner to 21.4 billion compared to the same period in 2012. The growth was driven by the three modern insulins and Victoza®. Victoza® sales of DKK 2,877 million in the second quarter of 2013 were primarily driven by the US and Europe. From a geographic perspective, North America and International Operations represented the majority of total sales growth. Sales growth in the second quarter of 2013 was positively impacted by 2 percentage points due to a number of non-recurring events including a
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reduction in the provision for rebates in North America as well as the timing of tenders and shipments in International Operations.
The gross margin increased to 83.1% in the second quarter of 2013 compared to 82.4% in the same period last year. The increase of 0.7 percentage point was driven by a positive impact from pricing in the US and a favourable product mix development. The gross margin was reduced by a negative currency impact of 0.7 percentage point.
In the second quarter of 2013, total non-production-related costs increased by 12% in local currencies and by 10% in Danish kroner to DKK 9,364 million compared to the same period last year.
Sales and distribution costs increased by 15% in local currencies and by 12% in Danish kroner in the second quarter of 2013 compared to the same period last year. The growth in costs is driven by the expansion of the US sales force in the second half of 2012, sales and marketing investments in China and selected countries in International Operations as well as an impact from reversals of legal provisions in the second quarter of 2012.
Research and development costs increased by 7% in local currencies and by 6% in Danish kroner in the second quarter of 2013 compared to the same period last year. The modest cost increase reflects timing of clinical trial activity and is primarily driven by the continued progress of key development projects within diabetes and biopharmaceuticals as well as the expansion of Novo Nordisks global research activities in the US and China.
Administration costs increased by 7% in local currencies and by 5% in Danish kroner in the second quarter of 2013 compared to the same period last year. The increase in costs is primarily driven by back-office infrastructure costs to support the expansion of the sales organisation in North America and International Operations as well as an impact from a cost refund in 2012 of a previously expensed fine related to an import licence for a major market in International Operations.
Operating profit in local currencies increased by 18% and by 12% in Danish kroner in the second quarter of 2013 compared to the same period last year.
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OUTLOOK 2013
The current
expectations for 2013 are summarised in the table below:
|
|
|
Expectations
are as reported, if not otherwise stated |
Current
expectations
8 August 2013 |
Previous
expectations
1 May 2013 |
|
||
Sales growth | ||
in local currencies | 11-13% | 9-11% |
as reported | Around
4 percentage points lower |
Around 3 percentage points lower |
|
||
Operating profit growth | ||
in local currencies | 12-15% | Around 10% |
as reported | Around
6 percentage points lower |
Around 5 percentage points lower |
|
||
Net financials | Income of
around DKK 900 million |
Income of
around DKK 900 million |
Effective tax rate | Around 23% | Around 23% |
Capital expenditure | Around DKK 3.5 billion | Around DKK 3.5 billion |
Depreciation,
amortisation and impairment losses |
Around DKK 3.0 billion | Around DKK 3.0 billion |
Free cash flow | Around DKK 22 billion | Around DKK 22 billion |
|
Novo Nordisk now expects sales growth in 2013 of 11-13% measured in local currencies. This reflects expectations for continued robust penetration for the portfolio of modern insulins, a continued steady Victoza® performance and a modest sales contribution from Tresiba®. These sales drivers are partly expected to be countered by generic competition to oral antidiabetic products, an impact from the challenging pricing environments in a number of major markets, intensifying competition within diabetes care as well as biopharmaceuticals and the macroeconomic conditions in a number of markets in International Operations. Given the current level of exchange rates versus the Danish krone, the reported sales growth is now expected to be around 4 percentage points lower than growth measured in local currencies.
For 2013, operating profit growth is now expected to be 12-15% measured in local currencies. This reflects the increased expectations for sales as well as significant costs related to the expanded sales force and sales and marketing investments in the portfolio of modern insulins and Victoza® in the US, the launch of Tresiba® outside the US, sales and marketing investments in China and in a selected number of countries in International Operations as well as a significant increase in costs related to the continued progress of key development projects within diabetes and biopharmaceuticals. Given the current level of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 6 percentage points lower than growth measured in local currencies.
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For 2013, Novo Nordisk still expects a net financial income of around DKK 900 million. The current expectation primarily reflects gains associated with foreign exchange hedging contracts following the depreciation of the Japanese yen and the US dollar versus the Danish krone compared to the average prevailing exchange rates in 2012.
The effective tax rate for 2013 is still expected to be around 23%.
Capital expenditure is still expected to be around DKK 3.5 billion in 2013, primarily related to investments in filling capacity and prefilled device production facilities and new offices in Denmark. Depreciation, amortisation and impairment losses are still expected to be around DKK 3.0 billion. Free cash flow is still expected to be around DKK 22 billion.
All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during 2013, and that currency exchange rates, especially for the US dollar, will remain at the current level versus the Danish krone. Please refer to appendix 7 for key currency assumptions.
Novo Nordisk has hedged expected net cash flows in a number of key invoicing currencies and, all other things being equal, movements in these key invoicing currencies will impact Novo Nordisks operating profit as outlined in the table below.
|
|
|
Key
invoicing
currencies |
Annual
impact on Novo Nordisks
operating profit of a 5% movement in currency |
Hedging
period
(months) |
|
|
|
USD | DKK 1,200 million | 12 |
JPY | DKK 200 million | 13 |
CNY | DKK 170 million | 12* |
GBP | DKK 85 million | 12 |
CAD | DKK 55 million | 9 |
|
|
|
* USD used as proxy when hedging Novo Nordisks CNY currency exposure |
The financial impact from foreign exchange hedging is included in Net financials.
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DIABETES CARE: INSULIN AND GLP-1
American Diabetes
Association (ADA) meeting 21-25 June 2013 in Chicago, USA
At the
annual meeting of the American Diabetes Association (ADA) held in Chicago, Novo
Nordisk presented results from the companys diabetes research and development
activities in 50 accepted abstracts, including three oral presentations and
two late-breaking abstracts. Among the key presentations was an oral presentation
of the phase 3 trial DUAL I with IDegLira, the combination product of
insulin degludec (Tresiba®) and liraglutide (Victoza®),
which included more than 1,600 patients with type 2 diabetes. The headline data
from DUAL I were previously announced in August 2012. In the trial, people
treated with IDegLira achieved an average HbA1c reduction of 1.9%
and 81% of the
people treated with IDegLira achieved the ADA and the European Association for
the Study
of Diabetes (EASD) HbA1c treatment target of 7%. People treated with
IDegLira experienced
a low rate of hypoglycaemia and achieved a reduction in weight.
Tresiba®
regulatory update
Novo
Nordisk has received feedback from FDA in the US on the clinical trial protocol
for the cardiovascular outcomes trial for Tresiba®. The feedback
from the agency confirmed the expectations announced by Novo Nordisk in May
2013 with regard to the trial design. The trial will be double-blind, use insulin
glargine as comparator and include around 7,500 patients. The basis for re-submission
of the new drug application is expected to be an interim analysis of major adverse
cardiovascular events in the trial, and Novo Nordisk will continue the trial
in order to make a definitive assessment of the cardiovascular safety of Tresiba®.
Following receipt of the feedback from FDA, Novo Nordisk has submitted the clinical
trial application in the US. The trial is now expected to be initiated towards
the end of 2013. Data to support the interim analysis is still expected to be
available between two to three years after trial initiation.
In June 2013, Novo Nordisk initiated a global 26-week, randomised, open-label, phase 3 trial comparing the efficacy and safety of Tresiba® and insulin glargine in approximately 800 people with type 2 diabetes. The trial will include patients from China and is expected to provide the basis for a regulatory submission with the Chinese Food and Drug Administration.
IDegLira (NN9068)
filed for regulatory approval in the EU and Switzerland
As announced
in May 2013, Novo Nordisk has submitted the marketing authorisation application
for IDegLira as a once-daily treatment of type 2 diabetes to the European Medicines
Agency. The filing of IDegLira is based on results from the DUAL clinical
trial programmes which involved around 2,000 people with type 2 diabetes, together
with the extensive clinical data generated in the development programmes of
the individual substances, insulin degludec (Tresiba®) and liraglutide
(Victoza®). Since the announcement in May, IDegLira has also
been filed for regulatory approval in Switzerland.
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Phase 3a programme
for liraglutide 3 mg (NN8022) for obesity successfully completed
Novo
Nordisk has now successfully completed the SCALE phase 3a clinical programme
investigating the efficacy and safety of liraglutide 3 mg for the treatment
of obesity.
In the SCALE programme, liraglutide 3 mg in combination with diet and exercise has consistently demonstrated, when compared to placebo, a clinically relevant larger weight loss and improvements in obesity-related risk factors, including blood glucose, blood pressure, cardiovascular risk biomarkers, lipids and patient-reported quality of life.
In May 2013, Novo Nordisk announced the headline results of the third trial in the SCALE programme, SCALE Obesity and Pre-diabetes, which included more than 3,500 people without diabetes who were obese, or overweight with comorbidities.
In this trial, people treated with liraglutide 3 mg achieved an average weight loss of 8.0% after 56 weeks of treatment compared to the 2.6% weight loss achieved by people treated with placebo. The proportion of people achieving a weight loss of at least 5% was 64% for liraglutide 3 mg and 27% for placebo. The proportion of people achieving a weight loss of at least 10% was 33% for liraglutide 3 mg and 10% for placebo treatment. All differences between liraglutide 3 mg and placebo were statistically significant and the trial met all co-primary endpoints. Furthermore, among those with pre-diabetes at randomisation, 69% treated with liraglutide 3 mg no longer showed signs of pre-diabetes after 56 weeks of treatment compared to 33% in the placebo-treated group. Liraglutide 3 mg was generally well tolerated and the 56-week completion rate was 72% and 64% for liraglutide 3 mg and placebo respectively. Withdrawals due to adverse events were below 10% in both treatment groups. The most common adverse events were related to the gastrointestinal system and they diminished over time.
Novo Nordisk has now completed the fourth and final trial in the SCALE programme, SCALE Sleep Apnoea. This 32-week trial investigated the effect of liraglutide 3 mg and placebo in combination with lifestyle intervention on the severity of sleep apnoea in 350 obese people with obstructive sleep apnoea. Obstructive sleep apnoea is commonly associated with obesity and is characterised by decreased or total arrest in airflow during breathing when asleep. Obstructive sleep apnoea is commonly assessed using the apnoea-hypopnoea index (AHI) measuring obstructed breathing events per hour.
In the trial, from a mean baseline index number of 49 on the AHI index, equal to severe obstructive sleep apnoea, people treated with liraglutide 3 mg experienced an improvement of 12 index points compared with 6 index points for those treated with placebo after 32 weeks of treatment. The difference was statistically significant and the trial thus met its primary endpoint.
In spite of its relatively short duration, the study further confirmed the weight loss efficacy of liraglutide 3 mg. From a baseline weight of 117 and 119 kg, respectively, people treated with liraglutide 3 mg and placebo achieved an average weight loss at 32 weeks of 5.7% and 1.6%.
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In the trial, liraglutide 3 mg was generally well-tolerated and the safety profile appeared to be consistent with that observed in the previous trials in the SCALE programme.
Novo Nordisk expects to file liraglutide 3 mg as a treatment for obesity for regulatory review in the US and EU around the turn of the year.
Phase 1 pump
study completed with FIAsp (NN1218) in people with type 1 diabetes
In June
2013, Novo Nordisk completed an exploratory double-blind phase 1 crossover trial
evaluating the short-term efficacy, safety and pump compatibility of continuous
subcutaneous infusion of FIAsp (a novel and faster acting insulin aspart formulation)
and NovoRapid® (insulin aspart) in 42 people with type 1 diabetes.
People were randomised to three treatment periods of 14 days with FIAsp and
NovoRapid® respectively. To assess post-prandial glucose control,
meal tests were conducted on the last day of each treatment period and blinded
continuous glucose monitoring was used throughout the trial.
In the trial, the meal tests showed that people treated with FIAsp experienced statistically significantly better glucose control during the first two hours after the meal, and the trial thus met its primary endpoint. The finding of reduced post-prandial glucose excursions at the meal tests were confirmed during other meals as assessed by continuous glucose monitoring. The rates of documented hypoglycaemia for people treated with FIAsp was furthermore numerically lower than for people treated with NovoRapid®.
In the trial, both FIAsp and NovoRapid® pump treatment appeared to be safe and was well-tolerated with good pump compatibility.
Based on the results from the phase 1 studies with FIAsp, Novo Nordisk expects to initiate the phase 3a programme, onset, anticipated to include around 3,000 people with type 1 or type 2 diabetes, during the third quarter of 2013.
Phase 1 development
successfully completed with Oral GLP-1, OG217SC (NN9924)
In May,
Novo Nordisk completed the last of five clinical pharmacology trials investigating
the safety, tolerability as well as pharmacokinetic and pharmacodynamic profiles
of oral administration of semaglutide tablets, OG217SC. The phase 1 programme
in total comprised 400 healthy volunteers and 10 people with type 2 diabetes.
In the trials, oral semaglutide treatment appeared to be safe and was well-tolerated. The most frequent reported adverse events were mild or moderate in severity and in line with observations from other GLP-1 class treatments.
In a 10-week multiple-dosing trial, oral administration of semaglutide was associated with a statistically significantly larger weight loss than placebo in healthy volunteers and people with type 2 diabetes. Further, a statistically significant improvement in HbA1c was observed when compared to placebo treatment in the low number of people with type 2 diabetes participating in the trial.
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Based on the results from the five clinical pharmacology trials, Novo Nordisk expects to initiate phase 2 development for OG217SC towards the end of 2013.
First human
dose achieved with new oral GLP-1, OG217GT (NN9928)
In May,
Novo Nordisk initiated the first phase 1 trial for another semaglutide tablet
formulation, OG217GT, using a different absorption enhancer technology. The
phase 1 trial will investigate the safety, tolerability and pharmacokinetics
of single and multiple doses of OG217GT in healthy volunteers.
BIOPHARMACEUTICALS: HAEMOPHILIA
First phase
3a trial with N9-GP (NN7999) for treatment of haemophilia B completed
In May, Novo Nordisk
announced the completion of paradigm 2, the first phase 3 trial with N9-GP
(glycopegylated recombinant factor IX), a long-acting FIX derivative, for haemophilia
B patients. In the trial, 74 patients were treated for six months on-demand,
or for 12 months using a prophylactic regimen of 10 U/kg or 40 U/kg N9-GP once
weekly.
The annualised median bleeding rate for patients treated on-demand was 15.6 episodes per year, whereas patients on prophylaxis had a median bleeding rate of 2.9 and 1.0 episodes per year when treated with weekly doses of 10 U/kg and 40 U/kg respectively.
Among patients randomised to receive 40 U/kg N9-GP, 99% of bleeding episodes were treated with only one infusion, and two-thirds of the patients experienced complete resolution of bleeding in their target joints. Patients in this dose group also reported an improvement in quality of life during the trial.
Pharmacokinetic data documented a high recovery rate and a steady state half-life of 110 hours.
In the trial, N9-GP appeared to have a safe and well-tolerated profile. No patients in the trial developed inhibitors, and no apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters.
Novo Nordisk is expecting the regulatory submission of N9-GP in 2015 following validation of the commercial scale production and completion of the two remaining phase 3 trials in the paradigm programme, covering surgery and paediatrics respectively.
Complete response
letter received from the US FDA for rFXIII for the treatment of congenital FXIII
deficiency
In June, Novo Nordisk
received a Complete Response Letter from the US Food and Drug Administration
(FDA) regarding its application to market a recombinant factor XIII compound
for congenital factor XIII deficiency, a rare bleeding disorder with which approximately
900 patients are diagnosed globally. In the Complete Response Letter, FDA informed
Novo Nordisk that completion of the review of the application is pending the
resolution of findings at an inspection of the manufacturing facility. Novo
Nordisk is working closely with FDA to address the issues.
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BIOPHARMACEUTICALS: HUMAN GROWTH HORMONE
Phase
1 trial completed for once-weekly growth hormone (NN8640) in healthy volunteers
In May, Novo Nordisk
completed a phase 1 study investigating safety, tolerability, pharmacokinetics
and pharmacodynamics of NN8640. In the trial, single and multiple doses of NN8640
were administered subcutaneously to healthy male volunteers. NN8640 appeared
to be safe and was well-tolerated. A dose-dependent IGF-I response was induced
by NN8640, and the IGF-I profiles indicate that the long-acting growth hormone
appears suitable for once-weekly dosing.
A multiple dose phase 1 study, investigating NN8640 in adults with growth hormone deficiency, is currently ongoing. Novo Nordisk expects to complete this trial in the second half of 2013.
BIOPHARMACEUTICALS: INFLAMMATION
Phase 2a trial
with recombinant FXIII (NN8717) in ulcerative colitis discontinued
In June, Novo Nordisk
discontinued a trial with recombinant FXIII investigating whether replenishment
of FXIII could provide a benefit in the treatment of ulcerative colitis. The
trial was discontinued, as the biological hypothesis of a relationship between
a low FXIII level and disease activity could not be confirmed.
Continued job
creation at Novo Nordisk
The number of full-time
equivalent employees was 35,869 as of 30 June 2013 compared to 32,819 as of
30 June 2012. New hiring was led by expansion in the US, countries in the International
Operations region, Research & Development and Product Supply.
Results from
DAWN2 show one in five feel discriminated against because of diabetes
In June, the first
results from the global DAWN2 study (Diabetes Attitudes, Wishes and Needs)
were presented at the annual meeting of the American Diabetes Association (ADA)
held in Chicago.
These results show that one in five people with diabetes feel discriminated against because of their condition and perceive support from the broader community as scarce. One in five family members also believes their relatives with diabetes face discrimination. Among diabetes healthcare professionals one out of three are concerned about discrimination and expressed a major need for improvement in the acceptance of people with diabetes as equal members in society.
DAWN2 is a global Novo Nordisk initiative conducted in collaboration with the International Diabetes Federation (IDF), the International Alliance of Patient Organisations (IAPO), the Steno Diabetes Center and a range of other national, regional and global partners. The study represents opinions from more than 15,000 people living with, or caring for people with diabetes in 17 countries across four continents.
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Total equity was DKK 35,357 million at the end of the second quarter of 2013, equivalent to 55.0% of total assets, compared to 51.4% at the end of the second quarter of 2012. Please refer to appendix 5 for further elaboration of changes in equity.
2013 share
repurchase programme
On 3 May, as part
of an overall programme of up to DKK 14 billion to be executed during a 12-month
period beginning 31 January 2013, Novo Nordisk announced a share repurchase
programme of up to DKK 3.0 billion to be executed from 6 May 2013 to 6 August
2013. The purpose of the programme is to reduce the companys share capital.
Under the programme, announced 3 May, Novo Nordisk has repurchased B shares
for an amount of DKK 3.0 billion in the period from 6 May 2013 to 6 August 2013.
The programme announced on 3 May was concluded on 6 August 2013.
As per 6 August 2013, Novo Nordisk A/S and its wholly-owned affiliates owned 16,317,924 of its own B shares, corresponding to 3.0% of the total share capital.
As of 6 August 2013, Novo Nordisk has repurchased a total of 8,800,573 B shares equal to a transaction value of DKK 8.5 billion under the DKK 14 billion programme beginning 31 January 2013.
As part of the execution of Novo Nordisk A/S ongoing share repurchase programme of up to DKK 14.0 billion to be executed during a 12-month period beginning 31 January 2013, a new share repurchase programme has been initiated in accordance with the provisions of the European Commissions regulation No 2273/2003 of 22 December 2003, also referred to as the Safe Harbour rules. For that purpose Novo Nordisk A/S has appointed Skandinaviska Enskilda Banken, Denmark, as lead manager to execute the programme independently and without influence from Novo Nordisk. Under the agreement, Skandinaviska Enskilda Banken, Denmark, will repurchase shares on behalf of Novo Nordisk A/S for an amount of up to DKK 2.5 billion during the trading period starting 8 August 2013 and ending on 29 October 2013. A maximum of 90,409 shares can be bought during one single trading day, equal to 20% of the average daily trading volume of Novo Nordisk B shares on NASDAQ OMX Copenhagen during the month of July 2013, and a maximum of 5,334,131 shares in total can be bought during the trading period. At least once every seven trading days, Novo Nordisk will issue an announcement in respect of the transactions made under the repurchase programme.
Product liability
lawsuits related to hormone therapy products
As of
5 August 2013, Novo Nordisk Inc, along with a majority of the hormone therapy
product manufacturers in the US, is a defendant in product liability lawsuits
related to hormone therapy products. These lawsuits currently involve a total
of 22 individuals who allege use of a Novo Nordisk hormone therapy product.
The products (Activella® and Vagifem®) have been
sold and marketed in the US since 2000. Until July 2003, the
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products were sold and marketed exclusively in the US by Pharmacia & Upjohn Company (now Pfizer Inc). In addition, 33 individuals currently allege, in relation to similar lawsuits against Pfizer Inc, that they have also used a Novo Nordisk hormone therapy product. Pfizer Inc has publicly announced the settlement of many of its hormone therapy cases. The continued reduction in pending cases is the result of Pfizer Inc settling several cases that also involve Novo Nordisks products. Currently, Novo Nordisk does not have any trials scheduled in 2013. Novo Nordisk does not expect the pending claims to have a material impact on its financial position, operating profit and cash flow.
Patent infringement
lawsuits related to Prandin®
In
the patent infringement lawsuit against Caraco Pharmaceutical Laboratories,
Ltd. (Caraco) regarding Caracos abbreviated new drug application (ANDA)
for a generic version of Prandin® (repaglinide), the U.S. Court
of Appeals for the Federal Circuit ruled in June affirming a 2011 District Court
decision that a claim in a Novo Nordisk patent related to the use of repaglinide
in combination with metformin for the treatment of type 2 diabetes was invalid,
and reversing the District Court decision that Novo Nordisk had committed inequitable
conduct during the time the company attempted to acquire the patent. Novo Nordisk
continues to believe in the validity of the patent and is reviewing the Federal
Circuit panel decision and considering its options with respect to further appeal.
Product liability
lawsuits related to Victoza®
Novo
Nordisk is per 5 August 2013 named in nine single-plaintiff lawsuits primarily
seeking to recover damages for pancreatic cancer experienced by patients who
allege to have been prescribed Victoza® and other GLP-1/DPP-IV
products. Eight of Novo Nordisks cases have been filed in California;
the ninth is venued in Louisiana. Eight of nine Novo Nordisk cases include other
defendants. Currently, Novo Nordisk does not have any trials scheduled in 2013.
Novo Nordisk does not expect the pending claims to have a material impact on
its financial position, operating profit and cash flow.
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FORWARD-LOOKING STATEMENTS | |
Novo Nordisks reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the companys Annual Report 2012 and Form 20-F, both filed with the SEC in February 2013, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: | |
| statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisks products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto |
| statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures |
| statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings |
| statements regarding the assumptions underlying or relating to such statements. |
In this document, examples of forward-looking statements can be found under the headings Outlook, Research and Development update, Equity and Legal matters.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this document, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisks products, introduction of competing products, reliance on information technology, Novo Nordisks ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in the Risk overview on p 43 of the Annual Report 2012 available on the companys website novonordisk.com.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a result of new information, future events or otherwise.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
22 of 30
|
The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S for the first half of 2013. The financial report has not been audited or reviewed by the companys independent auditors.
The financial report for the first half of 2013 has been prepared in accordance with IAS 34 Interim Financial Reporting and accounting policies set out in the Annual Report 2012 of Novo Nordisk. Furthermore, the financial report for the first half of 2013 and Managements Review are prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the accounting policies used are appropriate and the overall presentation of the financial report for the first half of 2013 is adequate. Furthermore, in our opinion, Management's Review includes a true and fair account of the development in the operations and financial circumstances, of the results for the period and of the financial position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group in accordance with Danish disclosure requirements for listed companies.
Besides what has been disclosed in the quarterly financial reports, no changes in the Groups most significant risks and uncertainties have occurred relative to what was disclosed in the consolidated annual report for 2012.
Bagsværd, 8 August 2013
Executive Management:
Lars
Rebien Sørensen
President
and CEO
|
Jesper
Brandgaard
CFO
|
Lars
Fruergaard Jørgensen
|
|
||
Lise
Kingo
|
Jakob
Riis
|
Kåre
Schultz
|
|
||
Mads
Krogsgaard Thomsen
|
||
|
||
|
||
Board
of Directors:
|
||
|
||
Göran
Ando
Chairman
|
Jeppe
Christiansen
Vice
chairman
|
Bruno
Angelici
|
|
||
Henrik
Gürtler
|
Liz
Hewitt
|
Ulrik
Hjulmand-Lassen
|
|
||
Thomas
Paul Koestler
|
Anne
Marie Kverneland
|
Søren
Thuesen Pedersen
|
|
||
Hannu
Ryöppönen
|
Stig
Strøbæk
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
23 of 30
|
APPENDIX 1: QUARTERLY NUMBERS IN DKK
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Amounts in DKK million, except number of full-time equivalent employees, earnings per share and number of shares outstanding). | ||||||||||||||
2013
|
2012
|
%
change
Q2 2013 vs Q2 2012 |
||||||||||||
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
||||
Sales |
21,380
|
19,983
|
20,962
|
19,845
|
19,468
|
17,751
|
10%
|
|||||||
Gross profit |
17,774
|
16,374
|
17,809
|
16,360
|
16,044
|
14,348
|
11%
|
|||||||
Gross margin |
83.1%
|
81.9%
|
85.0%
|
82.4%
|
82.4%
|
80.8%
|
||||||||
Sales and distribution costs |
5,834
|
5,530
|
6,192
|
5,299
|
5,203
|
4,850
|
12%
|
|||||||
Percentage of sales |
27.3%
|
27.7%
|
29.5%
|
26.7%
|
26.7%
|
27.3%
|
||||||||
Research and development costs |
2,715
|
2,657
|
3,210
|
2,617
|
2,563
|
2,507
|
6%
|
|||||||
Percentage of sales |
12.7%
|
13.3%
|
15.3%
|
13.2%
|
13.2%
|
14.1%
|
||||||||
Administrative costs |
815
|
801
|
991
|
766
|
779
|
776
|
5%
|
|||||||
Percentage of sales |
3.8%
|
4.0%
|
4.7%
|
3.9%
|
4.0%
|
4.4%
|
||||||||
Licence income and other operating income |
175
|
176
|
156
|
186
|
154
|
170
|
14%
|
|||||||
Operating profit |
8,585
|
7,562
|
7,572
|
7,864
|
7,653
|
6,385
|
12%
|
|||||||
Operating margin |
40.2%
|
37.8%
|
36.1%
|
39.6%
|
39.3%
|
36.0%
|
||||||||
Financial income |
363
|
315
|
17
|
(85)
|
146
|
47
|
149%
|
|||||||
Financial expenses |
267
|
108
|
137
|
420
|
856
|
375
|
(69%)
|
|||||||
Net financials |
96
|
207
|
(120)
|
(505)
|
(710)
|
(328)
|
(114%)
|
|||||||
Profit before income taxes |
8,681
|
7,769
|
7,452
|
7,359
|
6,943
|
6,057
|
25%
|
|||||||
Net profit |
6,734
|
5,982
|
5,755
|
5,667
|
5,346
|
4,664
|
26%
|
|||||||
Depreciation, amortisation and impairment losses |
676
|
691
|
755
|
644
|
656
|
638
|
3%
|
|||||||
Capital expenditure |
778
|
782
|
1,006
|
942
|
855
|
516
|
(9%)
|
|||||||
Net cash generated from operating activities1 |
7,283
|
7,070
|
1,514
|
7,962
|
7,151
|
5,587
|
2%
|
|||||||
Free cash flow1 |
6,423
|
6,178
|
408
|
6,926
|
6,273
|
5,038
|
2%
|
|||||||
Total assets |
64,289
|
62,447
|
65,669
|
66,620
|
60,978
|
61,210
|
5%
|
|||||||
Total equity |
35,357
|
33,801
|
40,632
|
35,660
|
31,334
|
32,358
|
13%
|
|||||||
Equity ratio |
55.0%
|
54.1%
|
61.9%
|
53.5%
|
51.4%
|
52.9%
|
||||||||
Full-time equivalent employees end of period |
35,869
|
35,154
|
34,286
|
33,501
|
32,819
|
32,252
|
9%
|
|||||||
Basic earnings per share/ADR (in DKK) |
12.52
|
11.04
|
10.59
|
10.40
|
9.72
|
8.38
|
29%
|
|||||||
Diluted earnings per share/ADR (in DKK) |
12.45
|
10.98
|
10.53
|
10.33
|
9.67
|
8.32
|
29%
|
|||||||
Average number of shares outstanding (million) |
537.7
|
541.6
|
542.9
|
544.6
|
549.1
|
556.7
|
(2%)
|
|||||||
Average number of diluted shares outstanding (million) |
540.5
|
544.7
|
546.0
|
547.8
|
552.4
|
560.5
|
(2%)
|
|||||||
Sales by business segment: | ||||||||||||||
Modern insulins (insulin analogues) |
9,626
|
8,991
|
9,462
|
8,879
|
8,613
|
7,867
|
12%
|
|||||||
Human insulins |
2,779
|
2,824
|
3,009
|
2,794
|
2,781
|
2,718
|
0%
|
|||||||
Victoza® |
2,877
|
2,678
|
2,709
|
2,503
|
2,293
|
1,990
|
25%
|
|||||||
Protein-related products |
643
|
606
|
621
|
644
|
621
|
625
|
4%
|
|||||||
Oral antidiabetic products (OAD) |
681
|
694
|
670
|
719
|
653
|
716
|
4%
|
|||||||
Diabetes care total |
16,606
|
15,793
|
16,471
|
15,539
|
14,961
|
13,916
|
11%
|
|||||||
NovoSeven® |
2,542
|
2,027
|
2,420
|
2,153
|
2,451
|
1,909
|
4%
|
|||||||
Norditropin® |
1,479
|
1,537
|
1,461
|
1,451
|
1,440
|
1,346
|
3%
|
|||||||
Other biopharmaceuticals |
753
|
626
|
610
|
702
|
616
|
580
|
22%
|
|||||||
Biopharmaceuticals total |
4,774
|
4,190
|
4,491
|
4,306
|
4,507
|
3,835
|
6%
|
|||||||
Sales by geographic segment: | ||||||||||||||
North America |
10,038
|
9,009
|
9,559
|
8,981
|
8,356
|
7,324
|
20%
|
|||||||
Europe |
5,123
|
4,761
|
5,237
|
4,793
|
5,081
|
4,596
|
1%
|
|||||||
International Operations |
3,077
|
3,094
|
2,894
|
2,695
|
2,757
|
2,734
|
12%
|
|||||||
Japan & Korea |
1,368
|
1,239
|
1,698
|
1,710
|
1,724
|
1,485
|
(21%)
|
|||||||
Region China |
1,774
|
1,880
|
1,574
|
1,666
|
1,550
|
1,612
|
14%
|
|||||||
Segment operating profit: | ||||||||||||||
Diabetes care |
5,965
|
5,502
|
5,420
|
5,768
|
5,270
|
4,638
|
13%
|
|||||||
Biopharmaceuticals |
2,620
|
2,060
|
2,152
|
2,096
|
2,383
|
1,747
|
10%
|
1Free cash flow for Q1 2012 and Q2 2012 has been reduced by DKK 1,328 million and increased by DKK 1,328 million, respectively, as withheld dividend tax is now presented as part of financing activities.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
24 of 30
|
APPENDIX
2: INCOME
STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
|
|
|
|
|
|
|
|
|
|
H1
|
H1
|
Q2
|
Q2
|
||||||
DKK million |
2013
|
2012
|
2013
|
2012
|
|||||
|
|
|
|
|
|
|
|
||
Income statement | |||||||||
Sales |
41,363
|
37,219
|
21,380
|
19,468
|
|||||
Cost of goods sold |
7,215
|
6,827
|
3,606
|
3,424
|
|||||
|
|
|
|
|
|
|
|
||
Gross profit |
34,148
|
30,392
|
17,774
|
16,044
|
|||||
Sales and distribution costs |
11,364
|
10,053
|
5,834
|
5,203
|
|||||
Research and development costs |
5,372
|
5,070
|
2,715
|
2,563
|
|||||
Administrative costs |
1,616
|
1,555
|
815
|
779
|
|||||
Licence income and other operating income |
351
|
324
|
175
|
154
|
|||||
|
|
|
|
|
|
|
|
||
Operating profit |
16,147
|
14,038
|
8,585
|
7,653
|
|||||
Financial income |
678
|
193
|
363
|
146
|
|||||
Financial expenses |
375
|
1,231
|
267
|
856
|
|||||
|
|
|
|
|
|
|
|
||
Profit before income taxes |
16,450
|
13,000
|
8,681
|
6,943
|
|||||
Income taxes |
3,734
|
2,990
|
1,947
|
1,597
|
|||||
|
|
|
|
|
|
|
|
||
NET PROFIT |
12,716
|
10,010
|
6,734
|
5,346
|
|||||
Basic earnings per share (DKK) |
23.56
|
18.10
|
12.52
|
9.72
|
|||||
Diluted earnings per share (DKK) |
23.43
|
17.99
|
12.45
|
9.67
|
|||||
Segment Information | |||||||||
Segment sales: | |||||||||
Diabetes care |
32,399
|
28,877
|
16,606
|
14,961
|
|||||
Biopharmaceuticals |
8,964
|
8,342
|
4,774
|
4,507
|
|||||
Segment operating profit: | Diabetes care |
11,467
|
9,908
|
5,965
|
5,270
|
||||
Operating margin |
35.4%
|
34.3%
|
35.9%
|
35.2%
|
|||||
Biopharmaceuticals |
4,680
|
4,130
|
2,620
|
2,383
|
|||||
Operating margin |
52.2%
|
49.5%
|
54.9%
|
52.9%
|
|||||
Total segment operating profit |
16,147
|
14,038
|
8,585
|
7,653
|
|||||
Statement of comprehensive income | |||||||||
Net profit for the period |
12,716
|
10,010
|
6,734
|
5,346
|
|||||
Other comprehensive income: | |||||||||
Items that will not be reclassified subsequently to the Income statement: | |||||||||
Remeasurements on defined benefit plans |
(52)
|
-
|
(52)
|
-
|
|||||
Items that will be reclassified subsequently to the Income statement, when specific conditions are met: | |||||||||
Exchange rate adjustments of investments in subsidiaries |
(10)
|
(109)
|
(167)
|
(135)
|
|||||
Cash flow hedges, realisation of previously deferred (gains)/losses |
(417)
|
838
|
(232)
|
441
|
|||||
Cash flow hedges, deferred gains/(losses) incurred during the period |
200
|
(528)
|
683
|
(1,115)
|
|||||
Other items |
(104)
|
18
|
(101)
|
(31)
|
|||||
Tax on other comprehensive income, income/(expense) |
(14)
|
(51)
|
(192)
|
271
|
|||||
|
|
|
|
|
|
|
|
||
Other comprehensive income for the period, net of tax |
(397)
|
168
|
(61)
|
(569)
|
|||||
|
|
|
|
|
|
|
|
||
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD |
12,319
|
10,178
|
6,673
|
4,777
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
25 of 30
|
|
|
|
|
|
|
DKK million |
30
Jun 2013
|
31
Dec 2012
|
|||
|
|
|
|
|
|
ASSETS | |||||
Intangible assets |
1,633
|
1,495
|
|||
Property, plant and equipment |
21,751
|
21,539
|
|||
Deferred income tax assets |
4,179
|
2,244
|
|||
Other financial assets |
201
|
228
|
|||
|
|
|
|
|
|
TOTAL NON-CURRENT ASSETS |
27,764
|
25,506
|
|||
Inventories |
9,660
|
9,543
|
|||
Trade receivables |
10,995
|
9,639
|
|||
Tax receivables |
728
|
1,240
|
|||
Other receivables and prepayments |
3,155
|
2,705
|
|||
Marketable securities |
3,053
|
4,552
|
|||
Derivative financial instruments |
864
|
931
|
|||
Cash at bank and on hand |
8,070
|
11,553
|
|||
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
36,525
|
40,163
|
|||
|
|
|
|
|
|
TOTAL ASSETS |
64,289
|
65,669
|
|||
|
|
|
|
|
|
EQUITY AND LIABILITIES | |||||
Share capital |
550
|
560
|
|||
Treasury shares |
(14)
|
(17)
|
|||
Retained earnings |
34,130
|
39,001
|
|||
Other reserves |
691
|
1,088
|
|||
|
|
|
|
|
|
TOTAL EQUITY |
35,357
|
40,632
|
|||
Deferred income tax liabilities |
813
|
732
|
|||
Retirement benefit obligations |
820
|
760
|
|||
Provisions |
1,879
|
1,907
|
|||
|
|
|
|
|
|
Total non-current liabilities |
3,512
|
3,399
|
|||
Current debt |
716
|
500
|
|||
Trade payables |
2,901
|
3,859
|
|||
Tax payables |
4,329
|
593
|
|||
Other liabilities |
9,748
|
8,982
|
|||
Derivative financial instruments |
33
|
48
|
|||
Provisions |
7,693
|
7,656
|
|||
|
|
|
|
|
|
Total current liabilities |
25,420
|
21,638
|
|||
TOTAL LIABILITIES |
28,932
|
25,037
|
|||
|
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES |
64,289
|
65,669
|
|||
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
26 of 30
|
APPENDIX 4: STATEMENT OF CASH FLOWS
|
|
|
|
|
|
DKK million |
H1
2013
|
H1
2012
|
|||
|
|
|
|
|
|
Net profit |
12,716
|
10,010
|
|||
Adjustment for non-cash items |
5,012
|
7,352
|
|||
Change in working capital |
(2,096)
|
(1,728)
|
|||
Interest received |
110
|
178
|
|||
Interest paid |
(20)
|
(19)
|
|||
Income taxes paid |
(1,369)
|
(3,055)
|
|||
|
|
|
|
|
|
Net cash generated from operating activities |
14,353
|
12,738
|
|||
Proceeds from intangible assets and other financial assets |
29
|
-
|
|||
Purchase of intangible assets and other financial assets |
(221)
|
(56)
|
|||
Proceeds from sale of property, plant and equipment |
6
|
15
|
|||
Purchase of property, plant and equipment |
(1,566)
|
(1,386)
|
|||
Net change in marketable securities |
1,499
|
750
|
|||
|
|
|
|
|
|
Net cash used in investing activities |
(253)
|
(677)
|
|||
Purchase of treasury shares, net |
(8,073)
|
(8,709)
|
|||
Dividends paid |
(9,715)
|
(7,742)
|
|||
|
|
|
|
|
|
Net cash used in financing activities |
(17,788)
|
(16,451)
|
|||
NET CASH GENERATED FROM ACTIVITIES |
(3,688)
|
(4,390)
|
|||
Cash and cash equivalents at the beginning of the period |
11,053
|
13,057
|
|||
Exchange gain/(loss) on cash and cash equivalents |
(11)
|
14
|
|||
|
|
|
|
|
|
Cash and cash equivalents at the end of the period |
7,354
|
8,681
|
|||
Additional information: | |||||
Cash and cash equivalents at the end of the period |
7,354
|
8,681
|
|||
Marketable securities at the end of the period |
3,053
|
3,323
|
|||
Undrawn committed credit facilities |
4,848
|
4,832
|
|||
|
|
|
|
|
|
FINANCIAL RESOURCES AT THE END OF THE PERIOD |
15,255
|
16,836
|
|||
Net cash generated from operating activities |
14,353
|
12,738
|
|||
Net cash used in investing activities |
(253)
|
(677)
|
|||
Net change in marketable securities |
(1,499)
|
(750)
|
|||
|
|
|
|
|
|
FREE CASH FLOW |
12,601
|
11,311
|
|||
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
27 of 30
|
APPENDIX 5: STATEMENT OF CHANGES IN EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
reserves
|
||||||||||||||||
|
||||||||||||||||
DKK million |
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjust- ments |
Cash
flow
hedges |
Tax
and
other adjust- ments |
Tota
lother reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H1 2013 | ||||||||||||||||
Balance at the beginning of the period |
560
|
(17)
|
39,001
|
226
|
847
|
15
|
1,088
|
40,632
|
||||||||
Net profit for the period |
12,716
|
12,716
|
||||||||||||||
Other comprehensive income for the period, net of tax |
(10)
|
(217)
|
(170)
|
(397)
|
(397)
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period |
560
|
(17)
|
51,717
|
216
|
630
|
(155)
|
691
|
52,951
|
||||||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends |
(9,715)
|
(9,715)
|
||||||||||||||
Share-based payment |
194
|
194
|
||||||||||||||
Purchase of treasury shares |
(8)
|
(8,098)
|
(8,106)
|
|||||||||||||
Sale of treasury shares |
1
|
32
|
33
|
|||||||||||||
Reduction of the B share capital |
(10)
|
10
|
-
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
550
|
(14)
|
34,130
|
216
|
630
|
(155)
|
691
|
35,357
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
reserves
|
||||||||||||||||
|
||||||||||||||||
DKK million |
Share
capital |
Treasury
shares |
Retained
earnings |
Exchange
rate adjust- ments |
Cash
flow
hedges |
Tax
and
other adjust- ments |
Total
other reserves |
Total
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H1 2012 | ||||||||||||||||
Balance at the beginning of the period |
580
|
(24)
|
37,111
|
398
|
(1,184)
|
567
|
(219)
|
37,448
|
||||||||
Net profit for the period |
10,010
|
10,010
|
||||||||||||||
Other comprehensive income for the period, net of tax |
(109)
|
310
|
(33)
|
168
|
168
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the period |
580
|
(24)
|
47,121
|
289
|
(874)
|
534
|
(51)
|
47,626
|
||||||||
Transactions with owners, recognised directly in equity: | ||||||||||||||||
Dividends |
(7,742)
|
(7,742)
|
||||||||||||||
Share-based payment |
159
|
159
|
||||||||||||||
Purchase of treasury shares |
(11)
|
(8,768)
|
(8,779)
|
|||||||||||||
Sale of treasury shares |
1
|
69
|
70
|
|||||||||||||
Reduction of the B share capital |
(20)
|
20
|
-
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
560
|
(14)
|
30,839
|
289
|
(874)
|
534
|
(51)
|
31,334
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
28 of 30
|
APPENDIX 6: REGIONAL SALES SPLIT
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2 2013 sales split per region | ||||||||||||
DKK million | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
North
America |
Europe
|
Inter-
national Operations |
Japan
&
Korea |
Region
China
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The diabetes care segment | ||||||||||||
NovoRapid ® |
4,283
|
2,544
|
952
|
414
|
242
|
131
|
||||||
% change in local currencies |
15%
|
19%
|
3%
|
29%
|
(1%)
|
39%
|
||||||
NovoMix ® |
2,484
|
715
|
616
|
464
|
205
|
484
|
||||||
% change in local currencies |
10%
|
20%
|
(5%)
|
16%
|
(6%)
|
22%
|
||||||
Levemir ® |
2,859
|
1,641
|
735
|
339
|
79
|
65
|
||||||
% change in local currencies |
20%
|
28%
|
2%
|
33%
|
(7%)
|
48%
|
||||||
Modern insulin |
9,626
|
4,900
|
2,303
|
1,217
|
526
|
680
|
||||||
% change in local currencies |
15%
|
22%
|
0%
|
24%
|
(4%)
|
27%
|
||||||
Human insulin |
2,779
|
516
|
613
|
799
|
130
|
721
|
||||||
% change in local currencies |
2%
|
23%
|
(9%)
|
4%
|
(21%)
|
4%
|
||||||
Victoza® |
2,877
|
1,841
|
747
|
165
|
85
|
39
|
||||||
% change in local currencies |
28%
|
29%
|
25%
|
62%
|
(10%)
|
117%
|
||||||
Other diabetes care |
1,324
|
515
|
225
|
180
|
108
|
296
|
||||||
% change in local currencies |
7%
|
10%
|
(8%)
|
16%
|
2%
|
14%
|
||||||
Diabetes care total |
16,606
|
7,772
|
3,888
|
2,361
|
849
|
1,736
|
||||||
% change in local currencies |
14%
|
23%
|
2%
|
18%
|
(7%)
|
15%
|
||||||
The biopharmaceuticals segment | ||||||||||||
NovoSeven® |
2,542
|
1,192
|
631
|
517
|
169
|
33
|
||||||
% change in local currencies |
6%
|
5%
|
(4%)
|
28%
|
16%
|
(32%)
|
||||||
Norditropin® |
1,479
|
564
|
448
|
140
|
323
|
4
|
||||||
% change in local currencies |
9%
|
34%
|
1%
|
(24%)
|
8%
|
0%
|
||||||
Other biopharmaceuticals |
753
|
510
|
156
|
59
|
27
|
1
|
||||||
% change in local currencies |
26%
|
52%
|
1%
|
10%
|
(43%)
|
0%
|
||||||
Biopharmaceuticals total |
4,774
|
2,266
|
1,235
|
716
|
519
|
38
|
||||||
% change in local currencies |
10%
|
19%
|
(2%)
|
12%
|
6%
|
(29%)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales |
21,380
|
10,038
|
5,123
|
3,077
|
1,368
|
1,774
|
||||||
% change in local currencies |
13%
|
22%
|
1%
|
16%
|
(3%)
|
14%
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
H1 2013 sales split per region | ||||||||||||
DKK million | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
North
America |
Europe
|
Inter-
national Operations |
Japan
&
Korea |
Region
China
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The diabetes care segment | ||||||||||||
NovoRapid ® |
8,300
|
4,917
|
1,853
|
817
|
466
|
247
|
||||||
% change in local currencies |
15%
|
20%
|
4%
|
28%
|
(1%)
|
40%
|
||||||
NovoMix ® |
4,884
|
1,374
|
1,219
|
944
|
402
|
945
|
||||||
% change in local currencies |
12%
|
21%
|
(3%)
|
18%
|
(4%)
|
26%
|
||||||
Levemir ® |
5,433
|
3,078
|
1,426
|
658
|
154
|
117
|
||||||
% change in local currencies |
19%
|
25%
|
4%
|
33%
|
(4%)
|
48%
|
||||||
Modern insulin |
18,617
|
9,369
|
4,498
|
2,419
|
1,022
|
1,309
|
||||||
% change in local currencies |
15%
|
22%
|
2%
|
25%
|
(3%)
|
30%
|
||||||
Human insulin |
5,603
|
962
|
1,210
|
1,632
|
253
|
1,546
|
||||||
% change in local currencies |
4%
|
25%
|
(9%)
|
8%
|
(23%)
|
7%
|
||||||
Victoza® |
5,555
|
3,561
|
1,384
|
373
|
167
|
70
|
||||||
% change in local currencies |
32%
|
35%
|
26%
|
51%
|
(6%)
|
123%
|
||||||
Other diabetes care |
2,624
|
1,005
|
434
|
346
|
208
|
631
|
||||||
% change in local currencies |
3%
|
9%
|
(14%)
|
8%
|
(1%)
|
6%
|
||||||
Diabetes care total |
32,399
|
14,897
|
7,526
|
4,770
|
1,650
|
3,556
|
||||||
% change in local currencies |
14%
|
24%
|
2%
|
19%
|
(7%)
|
16%
|
||||||
The biopharmaceuticals segment | ||||||||||||
NovoSeven® |
4,569
|
2,223
|
1,161
|
813
|
283
|
89
|
||||||
% change in local currencies |
7%
|
10%
|
2%
|
8%
|
7%
|
(10%)
|
||||||
Norditropin® |
3,016
|
1,052
|
873
|
469
|
615
|
7
|
||||||
% change in local currencies |
14%
|
33%
|
1%
|
15%
|
7%
|
0%
|
||||||
Other biopharmaceuticals |
1,379
|
875
|
324
|
119
|
59
|
2
|
||||||
% change in local currencies |
18%
|
30%
|
7%
|
15%
|
(28%)
|
0%
|
||||||
Biopharmaceuticals total |
8,964
|
4,150
|
2,358
|
1,401
|
957
|
98
|
||||||
% change in local currencies |
11%
|
19%
|
2%
|
11%
|
4%
|
(9%)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Total sales |
41,363
|
19,047
|
9,884
|
6,171
|
2,607
|
3,654
|
||||||
% change in local currencies |
14%
|
23%
|
2%
|
17%
|
(3%)
|
15%
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
29 of 30
|
APPENDIX 7: KEY CURRENCY ASSUMPTIONS
|
|
|
|
|
|
DKK per 100 |
2012
average
exchange rates |
YTD
2013 average
exchange rates as of 5 August 2013 |
Current
exchange rate as of 5 August 2013 |
||
|
|
|
|
|
|
USD |
579
|
568
|
562
|
||
JPY |
7.27
|
5.92
|
5.71
|
||
CNY |
91.82
|
91.89
|
91.82
|
||
GBP |
918
|
874
|
863
|
||
CAD |
580
|
557
|
541
|
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Financial report for the period 1 January 2013 to 30 June 2013 |
Page
30 of 30
|
APPENDIX 8: QUARTERLY NUMBERS IN USD (ADDITIONAL INFORMATION)
Key figures are translated into USD as additional information - the translation is based on the average exchange rate for income statement and the exchange rate at the balance sheet date for balance sheet items. The specified percent changes are based on the changes in the 'Quarterly numbers in DKK', see appendix 1.
%
change Q2 2013 vs Q2 2012 |
||||||||||||||
2013
|
2012
|
|||||||||||||
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
||||
Sales |
3,749
|
3,537
|
3,641
|
3,337
|
3,362
|
3,129
|
10%
|
|||||||
Gross profit |
3,117
|
2,898
|
3,093
|
2,752
|
2,771
|
2,529
|
11%
|
|||||||
Gross margin |
83.1%
|
81.9%
|
85.0%
|
82.4%
|
82.4%
|
80.8%
|
||||||||
Sales and distribution costs |
1,024
|
978
|
1,075
|
890
|
900
|
854
|
12%
|
|||||||
Percentage of sales |
27.3%
|
27.7%
|
29.5%
|
26.7%
|
26.7%
|
27.3%
|
||||||||
Research and development costs |
476
|
470
|
557
|
440
|
442
|
442
|
6%
|
|||||||
Percentage of sales |
12.7%
|
13.3%
|
15.3%
|
13.2%
|
13.2%
|
14.1%
|
||||||||
Administrative costs |
143
|
142
|
172
|
129
|
134
|
137
|
5%
|
|||||||
Percentage of sales |
3.8%
|
4.0%
|
4.7%
|
3.9%
|
4.0%
|
4.4%
|
||||||||
Licence income and other operating income |
31
|
31
|
27
|
31
|
27
|
30
|
14%
|
|||||||
Operating profit |
1,505
|
1,339
|
1,316
|
1,324
|
1,322
|
1,126
|
12%
|
|||||||
Operating margin |
40.2%
|
37.8%
|
36.1%
|
39.6%
|
39.3%
|
36.0%
|
||||||||
Financial income |
65
|
55
|
3
|
(15)
|
26
|
8
|
149%
|
|||||||
Financial expenses |
47
|
19
|
24
|
70
|
149
|
66
|
(69%)
|
|||||||
Net financials |
18
|
36
|
(21)
|
(85)
|
(123)
|
(58)
|
(114%)
|
|||||||
Profit before income taxes |
1,523
|
1,375
|
1,295
|
1,239
|
1,199
|
1,068
|
25%
|
|||||||
Net profit |
1,181
|
1,059
|
1,000
|
954
|
924
|
822
|
26%
|
|||||||
Depreciation, amortisation and impairment losses |
119
|
122
|
131
|
108
|
114
|
112
|
3%
|
|||||||
Capital expenditure |
137
|
138
|
175
|
159
|
148
|
91
|
(9%)
|
|||||||
Net cash generated from operating activities1 |
1,277
|
1,251
|
270
|
1,343
|
1,237
|
985
|
2%
|
|||||||
Free cash flow1 |
1,126
|
1,094
|
78
|
1,168
|
1,085
|
888
|
2%
|
|||||||
Total assets |
11,274
|
10,698
|
11,604
|
11,554
|
10,328
|
10,988
|
5%
|
|||||||
Total equity |
6,200
|
5,791
|
7,180
|
6,185
|
5,307
|
5,809
|
13%
|
|||||||
Equity ratio |
55.0%
|
54.1%
|
61.9%
|
53.5%
|
51.4%
|
52.9%
|
||||||||
Full-time equivalent employees end of period |
35,869
|
35,154
|
34,286
|
33,501
|
32,819
|
32,252
|
9%
|
|||||||
Basic earnings per share/ADR (in USD) |
2.20
|
1.95
|
1.84
|
1.75
|
1.68
|
1.48
|
29%
|
|||||||
Diluted earnings per share/ADR (in USD) |
2.19
|
1.94
|
1.83
|
1.74
|
1.67
|
1.47
|
29%
|
|||||||
Average number of shares outstanding (million) |
537.7
|
541.6
|
542.9
|
544.6
|
549.1
|
556.7
|
(2%)
|
|||||||
Average number of diluted shares | ||||||||||||||
outstanding (million) |
540.5
|
544.7
|
546.0
|
547.8
|
552.4
|
560.5
|
(2%)
|
|||||||
Sales by business segment: | ||||||||||||||
Modern insulins (insulin analogues) |
1,688
|
1,591
|
1,644
|
1,493
|
1,487
|
1,387
|
12%
|
|||||||
Human insulins |
487
|
500
|
523
|
469
|
479
|
479
|
0%
|
|||||||
Victoza® |
505
|
474
|
470
|
422
|
396
|
351
|
25%
|
|||||||
Protein-related products |
113
|
107
|
108
|
108
|
107
|
110
|
4%
|
|||||||
Oral antidiabetic products (OAD) |
119
|
123
|
116
|
122
|
113
|
126
|
4%
|
|||||||
Diabetes care total |
2,912
|
2,795
|
2,861
|
2,614
|
2,582
|
2,453
|
11%
|
|||||||
NovoSeven® |
446
|
359
|
420
|
362
|
423
|
337
|
4%
|
|||||||
Norditropin® |
259
|
272
|
254
|
244
|
249
|
237
|
3%
|
|||||||
Other biopharmaceuticals |
132
|
111
|
106
|
117
|
108
|
102
|
22%
|
|||||||
Biopharmaceuticals total |
837
|
742
|
780
|
723
|
780
|
676
|
6%
|
|||||||
Sales by geographic segment: | ||||||||||||||
North America |
1,761
|
1,594
|
1,659
|
1,514
|
1,443
|
1,291
|
20%
|
|||||||
Europe |
898
|
843
|
910
|
804
|
878
|
810
|
1%
|
|||||||
International Operations |
539
|
548
|
503
|
452
|
476
|
482
|
12%
|
|||||||
Japan & Korea |
240
|
219
|
295
|
287
|
298
|
262
|
(21%)
|
|||||||
Region China |
311
|
333
|
274
|
280
|
267
|
284
|
14%
|
|||||||
Segment operating profit: | ||||||||||||||
Diabetes care |
1,046
|
974
|
942
|
972
|
910
|
818
|
13%
|
|||||||
Biopharmaceuticals |
459
|
365
|
374
|
352
|
412
|
308
|
10%
|
1Free cash flow for Q1 2012 and Q2 2012 has been reduced by USD 234 million and increased by DKK 234 million, respectively, as withheld dividend tax is now presented as part of financing activities.
Financial
performance |
Outlook
|
R&D
|
Sustainability
|
Equity
|
Legal
|
Financial
information |
Company
announcement No 54 / 2013
|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: August 8, 2013 |
NOVO NORDISK A/S Lars Rebien Sørensen, President and Chief Executive Officer |